“If we put this study in context with everything else we know, we can definitely say there is a strong association between the use of Risperdal and gynecomastia,” says Dr. Mahyar Etminan, a UBC epidemiologist and lead researcher in the independent study.
“We know from case reports that Risperdal has the highest number of cases of reported gynecomastia and this study completes the puzzle.”
Using the information from a US health claims database of approximately one million men, Dr. Etminan’s team found that Risperdal users had a 69 percent higher risk of developing gynecomastia than non-Risperdal users. The data was presented at the American Association for Geriatric Psychiatry (AAGP) conference on March 15, in Orlando. The UBC study is the largest and first study of its kind.
Although the subjects in this study were older men, Dr. Etminan believes that gynecomastia connected to the use of Risperdal can also occur in younger boys.
Animal studies, done in the past, have demonstrated the pharmacological action of the drug and its powerful effect on neurotransmitters in the brain. “It is basically the strongest drug in terms of blocking dopamine receptors, and which in turn increases prolactin. That’s what we think causes the gynecomastia. We know the pharmacology that leads to the breast enlargement is there.”
The makers of Risperdal, Janssen Pharmaceuticals, a subsidiary of Johnson and Johnson, is the target of approximately 200 lawsuits in the US and Canada that claim the drug causes gynecomastia and other endocrine complications, including weight gain, damage to sexual function and diabetes.
Risperdal is used to treat schizophrenia and bipolar disorders in adults and adolescents. Last fall, the pharmaceutical giant was ordered to pay $2.2 billion in damages for civil and criminal liability for hiding dangerous side effects, and pursuing an aggressive marketing campaign designed to expand the use of Risperdal off-label to patient groups with Alzheimer’s and dementia.
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“We are drug safety researchers. We don’t have a speciality. We look at any drug class where there may be problems. There were case reports that alerted us to possible problems about Risperdal and that is why we began looking at it,” Dr. Etminan adds.
In addition to further Risperdal studies, the Etminan team is also turning its scientific attention to the controversial use of testosterone creams to enhance male libido and sexual function.